Assessment and Control of Endocrine Disruptorsby ECHA
First Annual Forum on Endocrine Disruptors
Brussels, 08.11.2019
Peter Lepper
Hazard Assessment Directorate
European Chemicals Agency, Helsinki
Chemicals legislations managed by ECHA
REACHRegistration
Evaluation
Authorisation
All chemicals
>1 tonne
per annum
CLPClassification
Labelling
Packaging
All chemicals
and mixtures
UN-wide standards
BPRBiocides
Active substances
and biocidal
products
PICPrior Informed
Consent
Import/export of
certain hazardous
chemicals
Rotterdam
Convention
Wealth of information unique in the world
Companies are required to collect or generate information on properties and
uses of their chemicals, assess the risks and recommend safety measures.
All this information is submitted to ECHA
How are endocrine disruptingchemicals regulated?
● REACH Regulation
● Biocidal Products Regulation
REACH contribution to managing endocrine
disrupters
Registration and screening
● The registration data together with other available information allows identification of potential EDs
● ECHA screens the data regularly and identifies candidates for further work by MSCAs and itself;
● Focus on fully registered substances and structurally similar substances
● Increasing focus on groups of substances
REACH contribution to managing endocrine
disrupters
Further information generation
● Further information on ED properties can be requested from industry: 88 substances on ECHA’s Community Rolling Action Plan for Substance Evaluation due to potential ED properties (18 more where ED concern identified while assessing other concerns)
● Assessments are not straightforward: ED expert groupsupports the Member States
ED Expert Group
57 external members
Meetings coordinated, hosted and chaired by ECHA: 3/year so far
ED EG provides informal and non-binding scientific advice on assessment of ED properties of chemicals
o More information on ECHA ED EG website (https://echa.europa.eu/endocrine-disruptor-expert-group)
o Contact: [email protected]
ED Assessment
Main references:
Widely accepted ED definition (WHO/IPCS, 2002): ED is an exogenous substance that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism or its progeny, or (sub)populations
Joint Research Centre ED Expert Advisory Group Report(https://op.europa.eu/en/publication-detail/-/publication/4b84ccc2-422d-4bd1-97da-1f414ad52c27)
European Food Safety Authority (EFSA) Opinion on identification of Eds(https://www.efsa.europa.eu/en/efsajournal/pub/3132)
OECD Guidance Document 150 on evaluating chemicals for endocrine disruption incl. conceptual framework for testing and assessment of EDs (http://www.oecd.org/publications/guidance-document-on-standardised-test-guidelines-for-evaluating-chemicals-for-endocrine-disruption-2nd-edition-9789264304741-en.htm)
Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009(https://www.efsa.europa.eu/en/efsajournal/pub/5311)
REACH contribution to managing endocrine
disruptersRegulatory risk management under REACH
● 16 substances included in the Candidate List due to ED properties - mainly phthalates and phenols including BPA
● Substances with ED properties are already subject to authorisation requirement and restrictions
● Authorisation aim: promote substitution and ensure high level of protection until the move to alternatives takes place
● Restriction aim: address unacceptable risks at community level
● REACH data and identification of the ED properties can be used as a basis to take action under other legislation
How are endocrine disruptingchemicals regulated?
● REACH Regulation
● Biocidal Products Regulation
Biocidal Products Regulation
• 2017 Commission Delegated Regulation sets out scientific criteria (PPPR: 2018)
• Based on WHO definition
• Applied from 7 June 2018 under BPR(under PPPR: November 2018)
• ECHA has developed, together withEFSA and JRC, technical guidancefor the implementation of the ED criteria(Published June 2018)
Route to final decisionIs there a clear
conclusion regarding ED properties?
Company submits
an application
Competent authority evaluates
Competent authority submits a report to
ECHA
BPC working group
BPC opinion
European Commission
ED expert
group
12
REACH
• 106 substances in Substance Evaluation (SEV)(88 on CoRAP with ED as initial concern plus 18 where ED concern identified while assessing for other concerns)
• 16 substances identified as SVHC (Candidate List)
• 7 substances placed on authorisation list (REACH Annex XIV)
• 5 substances placed on restriction list (REACH Annex XVII)
ED assessments carried outor in progress
Concluding remarks
Thank you!
peter.lepper(at)echa.europa.eu